Accelerated Development Of Solid Oral Dosage Formulation For IND Submission: Strategies For Rapid Execution And Compliance

By Saujanya Gosangari

The development of solid oral dosage forms, especially those with multiple active pharmaceutical ingredients (APIs), poses unique challenges in formulation, processing, and regulatory compliance. This white paper examines the accelerated development of a dual-active capsule formulation for Investigational New Drug (IND) submission, utilizing the roller compaction process. It details the integration of formulation optimization, process parameter establishment, and analytical method development, all within strict timelines.

As the demand for combination therapies grows, pharmaceutical companies face the challenge of creating effective, stable, and compliant multi-API formulations. This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.